Technical innovations for Annex 1

To meet the stringent EU GMP Annex 1 requirements, Optima presents innovative solutions to improve product and patient safety in pharmaceutical manufacturing. From minimising glove interventions and optimising First Air flow to advanced automation for integrity testing, this article explores how Optima's technologies support compliance in aseptic fill-and-finish processes

How does the current EU GMP Annex 1 affect fill-and-finish processes? What technical solutions and options does Optima offer to implement the new product and patient safety requirements?

Minimising glove interventions in isolators is a key goal of Annex 1. You will find an in-depth article specifically about this topic in this edition of the o-com. Annex 1 also focuses on the First Air principle in fill-and-finish processes. Since glove interventions can undermine the First Air principle, there is a close connection between “First Air” and glove minimisation - which also leads to overlap in the content of both contributions in terms of solutions. Therefore, some solutions are only mentioned in keywords and reference is made to the article, “Glove Minimization: The Path to Risk Minimization”. The contributions thus complement each other.

Regulatory principles

Today the Contamination Control Strategy (CCS) is the central basis for the handling processes of a pharmaceutical manufacturer. Another requirement of Annex 1 is Quality Risk Management (QRM). Processes must therefore be checked and evaluated according to a risk-based approach within the CCS. The QRM is, in turn, part of the overarching Pharmaceutical Quality System.